CA3107169A1 - Pharmaceutical dosage form which can be administered orally and has modified release - Google Patents

Pharmaceutical dosage form which can be administered orally and has modified release Download PDF

Info

Publication number
CA3107169A1
CA3107169A1 CA3107169A CA3107169A CA3107169A1 CA 3107169 A1 CA3107169 A1 CA 3107169A1 CA 3107169 A CA3107169 A CA 3107169A CA 3107169 A CA3107169 A CA 3107169A CA 3107169 A1 CA3107169 A1 CA 3107169A1
Authority
CA
Canada
Prior art keywords
disorders
compound
formula
weight
core
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CA3107169A
Other languages
English (en)
French (fr)
Inventor
Anke Stroyer
Carmen Lobback
Peter Serno
Kai Lovis
Philipp Rubenbauer
Heiko Schirmer
Danja Grossbach
Tia JACOBS
Britta Olenik
Julia Kusel
Donald Bierer
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bayer AG
Bayer Pharma AG
Original Assignee
Bayer AG
Bayer Pharma AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US16/043,567 external-priority patent/US10905667B2/en
Application filed by Bayer AG, Bayer Pharma AG filed Critical Bayer AG
Publication of CA3107169A1 publication Critical patent/CA3107169A1/en
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00—Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13—Crystalline forms, e.g. polymorphs
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C233/00—Carboxylic acid amides
    • C07C233/01—Carboxylic acid amides having carbon atoms of carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms
    • C07C233/45—Carboxylic acid amides having carbon atoms of carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms having the nitrogen atom of at least one of the carboxamide groups bound to a carbon atom of a hydrocarbon radical substituted by carboxyl groups
    • C07C233/53—Carboxylic acid amides having carbon atoms of carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms having the nitrogen atom of at least one of the carboxamide groups bound to a carbon atom of a hydrocarbon radical substituted by carboxyl groups with the substituted hydrocarbon radical bound to the nitrogen atom of the carboxamide group by a carbon atom of a six-membered aromatic ring
    • C07C233/55—Carboxylic acid amides having carbon atoms of carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms having the nitrogen atom of at least one of the carboxamide groups bound to a carbon atom of a hydrocarbon radical substituted by carboxyl groups with the substituted hydrocarbon radical bound to the nitrogen atom of the carboxamide group by a carbon atom of a six-membered aromatic ring having the carbon atom of the carboxamide group bound to a carbon atom of an unsaturated carbon skeleton
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C2601/00—Systems containing only non-condensed rings
    • C07C2601/02—Systems containing only non-condensed rings with a three-membered ring

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Urology & Nephrology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
CA3107169A 2018-07-24 2019-07-19 Pharmaceutical dosage form which can be administered orally and has modified release Pending CA3107169A1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
EP18185127 2018-07-24
US16/043,567 US10905667B2 (en) 2018-07-24 2018-07-24 Orally administrable modified-release pharmaceutical dosage form
US16/043,567 2018-07-24
EP18185127.0 2018-07-24
PCT/EP2019/069561 WO2020020789A1 (de) 2018-07-24 2019-07-19 Oral applizierbare pharmazeutische darreichungsform mit modifizierter freisetzung

Publications (1)

Publication Number Publication Date
CA3107169A1 true CA3107169A1 (en) 2020-01-30

Family

ID=67314781

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3107169A Pending CA3107169A1 (en) 2018-07-24 2019-07-19 Pharmaceutical dosage form which can be administered orally and has modified release

Country Status (22)

Country Link
EP (1) EP3826627B1 (https=)
JP (1) JP2021532113A (https=)
KR (1) KR20210035235A (https=)
CN (1) CN112469402B (https=)
AU (1) AU2019311234A1 (https=)
BR (1) BR112020026644A2 (https=)
CA (1) CA3107169A1 (https=)
CL (1) CL2021000160A1 (https=)
CO (1) CO2021000450A2 (https=)
CR (1) CR20210043A (https=)
DO (1) DOP2021000015A (https=)
EC (1) ECSP21003707A (https=)
IL (1) IL280083A (https=)
JO (1) JOP20210019A1 (https=)
MA (1) MA53368A (https=)
MX (1) MX2021000904A (https=)
PE (1) PE20210415A1 (https=)
PH (1) PH12021550170A1 (https=)
SG (1) SG11202100369WA (https=)
TW (1) TW202019402A (https=)
UY (1) UY38308A (https=)
WO (1) WO2020020789A1 (https=)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020245342A1 (en) 2019-06-07 2020-12-10 Bayer Aktiengesellschaft The use of sgc activators for the treatment of ophthalmologic diseases
CN112557533A (zh) * 2020-11-29 2021-03-26 北京康立生医药技术开发有限公司 一种恩格列净的分析方法
US20240317696A1 (en) * 2021-05-14 2024-09-26 Medshine Discovery Inc. Alkyl carboxylic acid compounds and application thereof
EP4536205A1 (en) 2022-06-09 2025-04-16 Bayer Aktiengesellschaft Soluble guanylate cyclase activators for use in the treatment of heart failure with preserved ejection fraction in women
CN117982443B (zh) * 2022-10-31 2026-03-06 优辉药业(北京)有限公司 一种达格列净二甲双胍缓释片剂

Family Cites Families (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3916899A (en) 1973-04-25 1975-11-04 Alza Corp Osmotic dispensing device with maximum and minimum sizes for the passageway
GB1478759A (en) 1974-11-18 1977-07-06 Alza Corp Process for forming outlet passageways in pills using a laser
US4063064A (en) 1976-02-23 1977-12-13 Coherent Radiation Apparatus for tracking moving workpiece by a laser beam
US4111202A (en) * 1976-11-22 1978-09-05 Alza Corporation Osmotic system for the controlled and delivery of agent over time
US4327725A (en) 1980-11-25 1982-05-04 Alza Corporation Osmotic device with hydrogel driving member
NZ206600A (en) 1983-05-11 1987-01-23 Alza Corp Osmotic drug delivery device
US4765989A (en) 1983-05-11 1988-08-23 Alza Corporation Osmotic device for administering certain drugs
ES2039287T3 (es) 1987-01-14 1993-09-16 Ciba-Geigy Ag Procedimiento para la obtencion de un sistema terapeutico peroral para productos activos dificilmente solubles.
DE19747261A1 (de) 1997-10-25 1999-04-29 Bayer Ag Osmotisches Arzneimittelfreisetzungssystem
DE19834044A1 (de) 1998-07-29 2000-02-03 Bayer Ag Neue substituierte Pyrazolderivate
DE19834047A1 (de) 1998-07-29 2000-02-03 Bayer Ag Substituierte Pyrazolderivate
ATE433318T1 (de) * 1999-02-10 2009-06-15 Pfizer Prod Inc Osmotisches system zur verabreichung von wirkstoffen, die feste amorphe dispersionen enthalten
AR031176A1 (es) 2000-11-22 2003-09-10 Bayer Ag Nuevos derivados de pirazolpiridina sustituidos con piridina
US20030161882A1 (en) 2002-02-01 2003-08-28 Waterman Kenneth C. Osmotic delivery system
DE10220570A1 (de) 2002-05-08 2003-11-20 Bayer Ag Carbamat-substituierte Pyrazolopyridine
DE102004062475A1 (de) 2004-12-24 2006-07-06 Bayer Healthcare Ag Feste, oral applizierbare pharmazeutische Darreichungsformen mit modifizierter Freisetzung
DE102008059206A1 (de) 2008-11-27 2010-06-10 Bayer Schering Pharma Aktiengesellschaft Pharmazeutische Darreichungsform enthaltend Nifedipin oder Nisoldipin und einen Angiotensin-II Antagonisten und/oder ein Diuretikum
DE102010021637A1 (de) 2010-05-26 2011-12-01 Bayer Schering Pharma Aktiengesellschaft Substituierte 5-Fluor-1H-Pyrazolopyridine und ihre Verwendung
PE20130779A1 (es) 2010-07-09 2013-06-21 Bayer Ip Gmbh Pirimidinas y triazinas condensadas y su uso
DE102010040233A1 (de) 2010-09-03 2012-03-08 Bayer Schering Pharma Aktiengesellschaft Bicyclische Aza-Heterocyclen und ihre Verwendung
DE102010043379A1 (de) 2010-11-04 2012-05-10 Bayer Schering Pharma Aktiengesellschaft Substituierte 6-Fluor-1H-Pyrazolo[4,3-b]pyridine und ihre Verwendung
DE102011007272A1 (de) * 2011-04-13 2012-10-18 Bayer Pharma Aktiengesellschaft Verzweigte 3-Phenylpropionsäure-Derivate und ihre Verwendung
UY34856A (es) * 2012-07-03 2013-12-31 Bayer Pharma AG Formas de presentación farmacéuticas que contienen 5-cloro-n-({(5s)-2-oxo-3-[4-(3-oxo-4- morfolinil)-fenil]-1,3-oxazolidin-5-il}-metil)-2-tiofencarboxamida
WO2019105881A1 (de) 2017-12-01 2019-06-06 Bayer Pharma Aktiengesellschaft Verfahren zur herstellung von (3s)-3-(4-chlor-3-{[(2s,3r)-2-(4-chlorphenyl)-4,4,4-trifluor-3-methylbutanoyl]amino}phenyl)-3-cyclopropylpropansäure und dessen kristalline form für die verwendung als pharmazeutischer wirkstoff

Also Published As

Publication number Publication date
JOP20210019A1 (ar) 2021-01-24
CN112469402A (zh) 2021-03-09
UY38308A (es) 2020-02-28
TW202019402A (zh) 2020-06-01
ECSP21003707A (es) 2021-02-26
MX2021000904A (es) 2021-03-31
KR20210035235A (ko) 2021-03-31
BR112020026644A2 (pt) 2021-03-23
CR20210043A (es) 2021-03-09
CN112469402B (zh) 2024-05-14
MA53368A (fr) 2021-06-02
CO2021000450A2 (es) 2021-01-29
PH12021550170A1 (en) 2021-09-13
EP3826627C0 (de) 2023-10-18
CL2021000160A1 (es) 2021-06-04
IL280083A (en) 2021-03-01
SG11202100369WA (en) 2021-02-25
AU2019311234A1 (en) 2021-02-04
WO2020020789A1 (de) 2020-01-30
EP3826627A1 (de) 2021-06-02
PE20210415A1 (es) 2021-03-04
DOP2021000015A (es) 2021-02-15
EP3826627B1 (de) 2023-10-18
JP2021532113A (ja) 2021-11-25

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Legal Events

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W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-1-1-W10-W00-W100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: LETTER SENT

Effective date: 20260129